Downstream Manufacturing Technician, Los Angeles, CA

This is a great opportunity for candidates with prior industry experience in cGMP manufacturing to grow in their career, while making an impact through immunotherapy products (such as COVID-19 therapies). Apply today for immediate consideration!

The Downstream Manufacturing Technician will be responsible for quality execution of all downstream Purification day-to-day floor manufacturing operations as well as all preparation activities on and off the manufacturing floor.  The candidate will also participate in cross-functional projects with Product Development (PD) and Process Science (PS) to develop, scale up and transfer new products.

Responsibilities

• Absolute advocate for SAFETY, exhibit and promote it at all times
• Assist in troubleshooting issues and coordinate resolutions to challenges
• Communicate transparently with management
• Execute process operations in accordance to dynamic production time-line
• Perform all aspects of Purification operations in accordance with cGMPs, including but not limited to:
• Column Chromatography (affinity, ion-exchange, mixed-mode, etc.)Viral Inactivation, Viral Filtration, Ultrafiltration/Diafiltration, Final Formulation, and Development of Bill of Materials lists as applicable
•   Develop and author necessary supporting cGMP documentation that supports all Purification manufacturing processes and operations above, including but not limited to:
• Equipment Use Logs, Standard Operating Procedures (SOPs), Batch Production Records, Raw Material Specifications

REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE)

• MS with 1-3 years, or BS with 2-5 years of cGMP Biopharmaceutical manufacturing industry experience in multi-product facilities
• Prior experience in manufacturing is preferred
• Prior hands?on experience for chromatography systems, such as AKTA process skids or DeltaV is preferred
• Experience in clinical and/or commercial?scale production operations subject to Current Good Manufacturing Practices (cGMP) regulations
• Strong interpersonal skills, a collaborator/ team player, inclusive to the diverse opinions of others
• Fluency with MS Office suite (Word/Excel/PowerPoint)
• Excellent oral and written communication skills
• Must be a self-starter and highly motivated
• Ability to multitask projects simultaneously, and prioritize projects
• Must have ability to perform work while wearing the appropriate gowning material for cleanroom environments and work under aseptic conditions in a class 100 environment (BSC)
• Ability to work weekends occasionally to support the dynamic production schedule and relevant time-lines
• Ability to occasionally work extended shift hours to support the dynamic production schedule and relevant time-lines
• Must have the ability to manage up to fifty (50) pounds at a time and stand for extended periods of time while wearing appropriate clean room gowning material and appropriate personal protective equipment is required
• *All hires are based on successful completion and passage of a background check.

Apply today for immediate consideration! If you’re unable to apply through the website, please email resumes and position title to JEND557@kellyscientific.com.

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